Facilitating Adjustment to Simulated Jet Lag

NCT ID: NCT05382923

Last Updated: 2022-05-19

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-07-10
• Study Completion Date: 2023-05-31

Brief Summary

The aims of this study are to compare 3 different treatments for circadian adjustment to a laboratory protocol which will mimic westward air travel across 8 time zones. One treatment will involve simply following the new schedule for 3 days. Another treatment will also involve exposure to bright light for 1 hour per day. A third treatment will involve exposure to bright light + exercise for 1 hour per day + consuming a melatonin tablet. Adjustment to the shifted schedule will be assessed by comparing measures of sleep, mood, mental performance, physical performance, and timing of melatonin across the 3 treatment conditions.

Detailed Description

Design Overview. Following a 1 week home baseline, N=36 young adults will spend 6 days in the laboratory (Figure 3 and Table 1). Following am 8 h baseline polysomnographic recording (PSG) on Night 1, participants will undergo a 26 h baseline circadian assessment via an ultrashort sleep-wake protocol involving 2 h wake intervals and 1 h sleep intervals, repeated throughout the protocol. Following baseline circadian assessment, participants will be placed on a 16 h wake-8 h sleep schedule in which the wake-sleep and light-dark schedule is delayed 8 h for 3 days (analogous to traveling 8 time zones west). Participants will be randomized to one of 3 treatments (n=12 per treatment) administered each of the 3 days of the shifted schedule: (1) placebo control, (2) bright light, and (3) bright light + exercise + melatonin. PSG recording will occur on the last night of the shifted schedule, followed by an end-of-study 26 h ultrashort sleep wake schedule. On baseline Day 1 and Days 2-3 of the shifted schedule, sleepiness, mood, and mental performance will be assessed every 3 h during wake. During all four 8 h sleep periods, sleep will also be recorded with the Z-machine, which assesses sleep stages from 3 EEG electrodes. During the ultrashort sleep-wake schedules, mental performance, physiological performance, urinary aMT6s, mood, and sleepiness will be measured around-the-clock.

Conditions

Circadian Rhythm Sleep Disorder, Jet Lag Type

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: SINGLE

Study Groups

Bright Light Alone

Bright light administered with Re-Timer glasses for 1 hour on 3 consecutive days. Following the 8 hour delay of the light/dark and sleep/wake cycle in the laboratory, the light will be administered, on average at 5:30-6:30 pm, 7:00-8:00 pm, and 9:30-10:30 pm, respectively on these three days.

Group Type: EXPERIMENTAL

Bright Light

Intervention Type: BEHAVIORAL

3 consecutive days of 1 hour bright light

Bright Light + Exercise + Melatonin

Bright light will be administered with Re-Timer glasses for 1 hour on 3 consecutive days. Following the 8 hour delay of the light/dark and sleep/wake cycle in the laboratory, the light will be administered, on average at 5:30-6:30 pm, 7:00-8:00 pm, and 9:30-10:30 pm, respectively on these three days. Exercise (1 hour at 65-75% heart rate reserve) will be administered on 3 consecutive, at 1:30-2:30 pm, 4:00-5:00 pm, and 6:30-7:30 pm on these days. Melatonin (0.5 mg) will be administered at 6 am, 8:30 am, and 11:00, on the 3 days.

Group Type: EXPERIMENTAL

Bright Light + Exercise + Melatonin

Intervention Type: BEHAVIORAL

3 consecutive days of bright light, exercise, and melatonin

Placebo Control

Dim red light will be administered with Re-Timer glasses for 1 hour on 3 consecutive days. Following the 8 hour delay of the light/dark and sleep/wake cycle in the laboratory, the light will be administered, on average at 5:30-6:30 pm, 7:00-8:00 pm, and 9:30-10:30 pm, respectively on these three days. Placebo tablets (0.5 mg) will be administered at 6 am, 8:30 am, and 11:00, on the 3 days.

Group Type: PLACEBO_COMPARATOR

Control

Intervention Type: BEHAVIORAL

3 consecutive days of dim red light + light stretching + placbo

Interventions

Bright Light

3 consecutive days of 1 hour bright light

Intervention Type: BEHAVIORAL

Bright Light + Exercise + Melatonin

3 consecutive days of bright light, exercise, and melatonin

Intervention Type: BEHAVIORAL

Control

3 consecutive days of dim red light + light stretching + placbo

Intervention Type: BEHAVIORAL

Other Intervention Names

Bright Light Treatment; Bright Light Treatment + Treadmill Exercise + Melatonin; Placebo Control

Eligibility Criteria

Inclusion Criteria

1. age 18-45 years

2. At least moderate level of habitual physical activity (twice per week, 20 min of aerobic exercise at 60% of maximal effort or higher

Exclusion Criteria

(1)Having more than one risk factor for coronary artery disease: (2) having any symptom or sign of cardiopulmonary disease; (3) recent shift-work experience (previous 2 months) or travel across multiple time zones (previous 4 weeks); (4) having an abnormal sleep-wake schedule (i.e., reported bedtime before 9:00 pm or after 2:00 am; wake time before 5:00 am or after 10:00 am); (5) being an extreme night owl or morning lark, as assessed by the Horne-Ostberg Mornngness-Eveningness Scale;70 (6) having a high risk sleep apnea or another sleep disorder; (7) depressed mood [Center for Epidemiologic Studies-Depression Scale (CES-D) > 16];71 (7) use of medications likely to distort melatonin excretion or cardiovascular responses to exercise; (8) use of sleeping pills more than 1 night per week; (9) having high sensitivity to light; (10) abuse of alcohol or drugs (amount per week; related problems such as missing work); (11) any physical or mental health condition that would contraindicate participation in exercise or other rigors of the experiment.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of California, San Diego

OTHER

Sponsor Role: collaborator

University of Arizona

OTHER

Sponsor Role: lead

Responsible Party

Shawn Youngstedt

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Shawn Youngstedt, PhD

Role: PRINCIPAL_INVESTIGATOR

Univ Arizona

Salma Patel, MD

Role: PRINCIPAL_INVESTIGATOR

University of Arizona

Locations

Center Sleep and Circadian Sciences

Tucson, Arizona, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Shawn Youngstedt, PhD

Role: CONTACT

youngstedt@email.arizona.edu

803-767-3208

Salma Patel, MD

Role: CONTACT

salmapatel@arizona.edu

480-768-7880

Facility Contacts

Sairam Parthasarethy, MD

Role: primary

sparthasarathy@deptofmed.arizona.edu

Other Identifiers

2011240758

Identifier Type: -

Identifier Source: org_study_id